EAPA Litigation

Under the Enforce and Protect Act, CBP investigates whether a company is evading particular antidumping and countervailing duty orders. Litigation on determinations made under the relatively new statute have centered on due process protections for respondents, CBP's evidentiary basis for its decisions and the interplay of decisions made on the scope of the applicable AD/CVD orders from both CBP and the Commerce Department. The Court of Appeals for the Federal Circuit issued a key decision for all EAPA cases in Royal Brush Manufacturing v. United States, when it found CBP to have violated a respondent's due process protections by failing to provide it with access to the business proprietary information used in the proceeding.

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New and Revised FDA Import Alerts for Dec. 30

December 31, 2014 |FDA

On Dec. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA to Allow Grace Period for Drug Supply Chain Law's Product Tracing Requirements

December 29, 2014 |FDA

Pharmaceutical manufacturers, distributors and repackagers will be given a four-month grace period before having to comply with product tracing requirements under the Drug Supply Chain Security Act (DSCSA), said the Food and Drug Administration in a guidance document issued Dec. 24 (here). Under DSCSA, “trading partners” are required to provide the next purchaser in the supply chain with product tracing information when engaging in transactions involving prescription drugs, and must maintain the information for at least six years after the relevant transaction. The product tracing requirements were set to take effect on Jan. 1, but in response to concern that “unforeseen complications” could disrupt the supply chain and impact patients’ access to needed prescription drugs, FDA will give manufacturers, wholesale distributors, and repackagers until May 1, 2015 before taking action against trading partners who are not in compliance, it said.

New and Revised FDA Import Alerts for Dec. 24

December 24, 2014 |FDA

On Dec. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Other Modified FDA Import Alerts for the Week of Dec. 15-21

December 23, 2014 |FDA

During the week of Dec. 15-21, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:

New and Revised FDA Import Alerts for Dec. 22

December 23, 2014 |FDA

On Dec. 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Revises Staff Compliance Guide on Labeling of Processed Seafood Made With Fish Protein

December 23, 2014 |FDA

The Food and Drug Administration announced revisions to its Compliance Policy Guide on labeling of processed and blended seafood products made primarily with fish protein (here). Changes to the guide, which is used by FDA staff, include revisions for “clarity and format, with new sections on regulatory action guidance and specimen changes.

FDA Issues Guidance on Labeling of FDA-Regulated Beers

December 23, 2014 |FDA

The Food and Drug Administration is finalizing guidance on the labeling of beers that are subject to FDA jurisdiction (here). Certain beers, which are not made from both malted barley and hops but are instead made from substitutes for malted barley (such as sorghum, rice, or wheat) or are made without hops, do not meet the definition of a “malt beverage” under the Federal Alcohol Administration Act. Such products (other than sake, which is classified as a wine under the FAA Act), are not subject to the labeling provisions of the Alcohol and Tobacco Tax and Trade Bureau, and instead must follow FDA labeling regulations. FDA’s guidance explains the application of its labeling regulations to non-TTB regulated beers.

New and Revised FDA Import Alerts for Dec. 19

December 22, 2014 |FDA

On Dec. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for Dec. 18

December 19, 2014 |FDA

On Dec. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for Dec. 17

December 19, 2014 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Dec. 17 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.